Cleared Traditional

MR Wireless Gating System, Model WGS-100

K171778 · Ivy Biomedical Systems, Inc. · Radiology
Mar 2018
Decision
272d
Days
Class 2
Risk

About This 510(k) Submission

K171778 is an FDA 510(k) clearance for the MR Wireless Gating System, Model WGS-100, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Ivy Biomedical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on March 14, 2018, 272 days after receiving the submission on June 15, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K171778 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2017
Decision Date March 14, 2018
Days to Decision 272 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code LNH — System, Nuclear Magnetic Resonance Imaging
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

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